Cookie consent(s)
We use cookies to personalize content and ads, provide social media features, and analyze traffic. This is done only with your explicit consent. By clicking "ACCEPT ALL," you agree to the processing and sharing of your data with our partners for social media, advertising, and analytics, including in third countries in accordance with Art. 49(1)(a) GDPR and Art. 17(1)(a) FADP (Switzerland). There is a risk that your data may be monitored by authorities without legal recourse. You can change or revoke your consents at any time in the data privacy settings .
Data protection declaration | Legal notices
Settings
Medical Cybersecurity

Safeguarding Patient Safety Trough Secure Medical Devices

Contact us

Safeguarding Health by Implementing Security by Design

The growth of digital innovation and its application into the healthcare industry has completely transformed the industry. While it has brought, multiple efficiency improvements, it also presents several new threat scenarios. As medical devices rely on components, networks and software technology, enhancing cybersecurity for medical devices is critical to protect patient’s personal information in order to provide secure patient care.
With DEKRA’s testing and certification services, medical device manufacturers can navigate their way through a complex landscape of medical cybersecurity standards and baseline requirements before entering international markets.
Medical Cybersecurity Key Benefits

DEKRA Medical Cybersecurity Services

DEKRA offers a comprehensive portfolio of medical cybersecurity services to manufacturers worldwide to comply with international healthcare requirements and standards.
Cybersecurity Training
To provide organizations understanding of cybersecurity for medical devices, we offer global medical cybersecurity trainings sessions to raise awareness and comprehension about the implementation of international standards and requirements established in regulatory frameworks such as:
  • IEC 81001-5-1
  • IEC 60601-4-5
  • EU Requirements
  • FDA Requirements
  • ANSI/UL 2900-2-1
Cybersecurity Testing
Other Relevant Standards in Medical Cybersecurity

Empowering Healthcare with Secure Medical Devices by DEKRA

By choosing DEKRA, you benefit from proven expertise, extensive experience, exceptional customer service, and with a strong commitment to medical cybersecurity. We provide Notified Body CE certification services that allow manufacturers to bring medical devices into the European market while meeting stringent regulatory standards. 
Related Services
Medical Device Regulation (MDR)
Manufacturers of medical devices must comply with this European regulation to prove that the continuously evolving and innovative devices remain secure and reliable.
Details
In Vitro-Diagnostic Regulation (IVDR)
Through this regulation, manufacturers demonstrate compliance with analytical and clinical performance requirements while reinforcing responsibility to safety.
Details